FDA approves expanded use of HPV 9-valent vaccine recombinant to include individuals aged 27-45 years

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October 9, 2018

FDA approves expanded use of HPV 9-valent vaccine recombinant to include individuals aged 27-45 years

FDA has approved a supplemental application for the human papillomavirus 9-valent vaccine, recombinant (Gardasil 9—Merck, Sharp & Dohme Corp.) to widen the approved use of the vaccine to include women and men aged 27–45 years.

FDA has approved a supplemental application for the human papillomavirus 9-valent vaccine, recombinant (Gardasil 9—Merck, Sharp & Dohme Corp.) to widen the approved use of the vaccine to include women and men aged 27–45 years. "Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," said Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research. "CDC has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing." FDA approved Gardasil 9, which protects against nine HPV types, in 2014 for use in males and females aged 9–26 years. The safety of Gardasil 9 was evaluated in about 13,000 individuals, and the most frequently reported adverse reactions were injection site pain, swelling, redness, and headaches. According to FDA, a study of about 3,200 women aged 27–45 years followed for an average of 3.5 years, found that Gardasil—which was approved in 2006 to prevent certain cancers and diseases caused by four HPV types and is no longer distributed in the U.S—was 88% effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. FDA's approval of Gardasil 9 in women aged 27–45 years of age is based on these results and new data on long-term followup from this study. The agency noted that Gardasil 9's efficacy in men aged 27–45 years "is inferred from the data described above in women 27–45 years of age, as well as efficacy data from Gardasil in younger men (16–26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27–45 years of age, received a 3-dose regimen of Gardasil over 6 months."